New guidelines for stem cell and embryo research from the ISSCR

The guidelines from the International Society for Stem Cell Research (ISSCR) provide regulators and research funders with a framework regulatory oversight of stem cell clinical translation, including recent advances related to embryo models, chimeric embryos, mitochondrial replacement. creation embryos is not permitted in many countries. However, vitro fertilization (IVF) practiced widely commonly leads that are suitable use or excess need. Embryos would otherwise be discarded can donated, informed consent, could improve fertility treatment reduce congenital disease, such as through replacement techniques (MRTs). Recent have shown MRTs performed successfully enabled generation embryo-like structures pluripotent human lines culture, offering opportunities these, instead study early development. There also been capacity generate animal containing cells may someday offer possibility generating organs transplantation. new required validate these models determine circumstances under which proceed ethically. ISSCR Guidelines Clinical Translation (https://www.isscr.org/guidelines), updates published on May 26, 2021, scientifically ethically rigorous guidance this research. were written by task force included scientists, clinicians, bioethicists, experts. They address involving organoids, cell-based genome editing (Lovell-Badge et al., 2021Lovell-Badge L. Anthony E. Barker R. Bubela T. Brivanlou A. Carpenter M. Charo R.A. Clark Clayton Cong Y. al.ISSCR Translation: 2021 Update.Stem Reports. 2021; 16 (in press. Published online 27, 2021)https://doi.org/10.1016/j.stemcr.2021.05.012Abstract Full Text PDF Scopus (34) Google Scholar) weighing scientific benefits against unique issues posed establish clear boundaries permissible basis process evaluate ethical issues. We discuss areas where should consider revising policies hinder promising MRTs. created using clusters culture resemble embryos. Importantly, opportunity has potential assisted reproduction advance our understanding development (Hyun 2020Hyun I. Munsie Pera M.F. Rivron N.C. Rossant J. Toward Human Embryo Models Formed Cells.Stem 2020; 14: 169-174Abstract PubMed (44) Scholar). Previous versions precluded more than 14 days had develop into viable organisms. updated drop concept because it an ambiguous threshold: unknown if transplanted vivo. Instead, categorize all permissible, exception no model transferred uterus animal, establishing standard review committees will prevent attempts pregnancies describe categorizes according their complexity anticipated ability undergo further relevant embryonic extraembryonic types sustain (e.g., blastoids) must reviewed specialized Several world’s leading categorial restrictions (Matthews Moralí, 2020Matthews K.R. Moralí D. National embryoid policies: survey 22 top research-intensive countries.Regen. Med. 15: 1905-1917Crossref (28) For example, year US Institutes Health (NIH) sent mixed messages about whether they support concerned developmental some cause them fall “Dickey-Wicker Amendment,” annual spending rider prohibits federal funds involves destruction (Public Law No: 116-260). Similarly, Australia’s Medical Council interpreted 2002 law regarding restrict beyond days. Given allow scientists periods without funding agencies when falls within parameters outlined guidelines. stated goal supported Dickey-Wicker Amendment, gametes research, derived culture. transferring area lead production transplantation (Masaki Nakauchi, 2017Masaki H. Nakauchi Interspecies chimeras research.Development. 2017; 144: 2544-2547Crossref (19) poses challenges. described enables incrementally, while imposing guardrails crossing sensitive need avoid high levels chimerism certain tissues after birth, nervous system germline. Depending goals, concerns managed allowing animals born, restricting cells, preventing breeding. consistent regulations countries UK important restrictions. Japan allowed updating 2019 enable aimed at (Sawai 2019Sawai Hatta Fujita Significantly Relaxes Its Human-Animal Chimeric Regulations.Cell Cell. 2019; 24: 513-514Abstract (12) Unfortunately, US, NIH restricted since 2015, despite considering, but never finalizing, policy Instead current moratorium, other policymakers proposed Guidelines. Mitochondria produce much energy oxidative metabolism. While vast majority genes encoded nuclear genome, mitochondria own encodes proteins essential Consequently, people normal genomes severe defects function. Mitochondrial DNA uniquely inherited mother. Some women carry proportion abnormal oocytes cannot biologically children do suffer diseases marked wide range health problems muscle weakness, delays, neurological respiratory problems. families healthy, biological parents (unmutated) oocyte donor. resulted successful pregnancies, technology continue refined closely overseen regulators. recommend limiting initial uses cases probability transmitting regulations. countries, Canada, due broad heritable distinguish between (Cohen 2020Cohen I.G. Adashi E.Y. Gerke S. Palacios-González C. Ravitsky V. Regulation Replacement Techniques Around World.Annu. Rev. Genomics Hum. Genet. 21: 565-586Crossref (11) Policymakers revise MRT continuing prohibit germline reproductive purposes humans. More safe appropriate perform hold great improving advancing reproduction; however, reformed justifiable way forward. R.L.-B. serves number advisory boards covered manuscript. positions listed follows, unpaid: co-opted member Scientific Advances Advisory Committee Fertility Authority (HFEA), 2006–present; Sense About Science, Member Board Trustees, March 2014–present; Public Library Science (PLOS), (and Chair Audit Committee, Remunerations Board), February 2012–present; Royal Society, “Genetic Technologies Programme,” April 2017–present; Progress Educational Trust, January 2019–present; WHO Expert Developing Global Standards Governance Oversight Genome Editing, Working Group, External Board, “Cambridge Reproduction Strategic Initiative,” University Cambridge, UK, 2021–present. S.M. board chairs Policy ISSCR. E.A. manager public Council, https://www.nhmrc.gov.au/about-us/news-centre/nhmrc-statementNational Health, https://grants.nih.gov/grants/guide/notice-files/NOT-OD-15-158.htmlNational https://grants.nih.gov/grants/guide/notice-files/not-od-16-128.htmlNational https://osp.od.nih.gov/2021/03/11/human-embryo-development/Public 116-260: Consolidated Appropriations Act (2020), https://www.congress.gov/bill/116th-congress/house-bill/133/text